Tag Archive for: Authorisation

EU Commission Releases Roadmap on Substances of Very High Concern

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EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.

EU Member State Committee Identifies 5 More SVHCs

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REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.

ChemSec Adds 22 Chemicals to "SIN List"

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REACh:

On May 3, 2011, the EU environmental group, the International Chemical Secretariat (ChemSec), announced the addition of 22 chemicals to its so-called “Substitute It Now!” list or “SIN List.”  ChemSec supposedly selected the chemicals based “solely” on their endocrine disrupting properties.  Although there is no established EU definition for what constitutes an endocrine disrupting chemical (EDC), according to the USEPA and the NRDC, an endocrine disruptor is a synthetic chemical that, upon absorption into the body, either mimics or blocks hormones and disrupts the body’s normal functions.  According to ChemSec’s press release, EDCs “interfere with our hormone system and have been increasingly linked to a range of health problems including cancer, diabetes, behavioural and attention deficit disorders, as well as impaired fertility.” The group added the chemicals in part to force EU regulators to begin selecting EDCs for the authorization process set out in the EU’s primary chemical control law, titled “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the Substance of Very High Concern (SVHC) criteria established under REACh.  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which contemplates substitution of such chemicals for those that are “safer.”  ChemSec developed the list to encourage early substitution and to suggest “candidates” for authorization.

According to ChemSec, many of the 22 chemicals are “commonly found in toys, food packaging, and cosmetics….”  The chemicals that ChemSec selected are:

  • 3-benzylidene camphor
  • 4-methylbenzylidene camphor
  • 4-nitrophenol
  • 4,4´-dihydroxybenzophenone
  • Benzophenone-1
  • Benzophenone-2
  • Benzophenone-3
  • Butylparaben
  • Dicyclohexyl phthalate (DCHP)
  • Diethyl phthalate (DEP)
  • Dihexyl phthalate (DHP)
  • Ethylhexyl methoxycinnamate
  • Metam natrium
  • Methyl tertiary butyl ether (MTBE)
  • Pentachlorophenol
  • Perchloroethylene
  • Propylparaben
  • Quadrosilan
  • Resorcinol
  • Tert-butylhydroxyanisole
  • Thiram
  • Zineb

Thus far, the European Commission has embraced the SIN List and its recent additions. On May 19, 2011, in his opening speech at the annual Helsinki Chemicals Forum, Janez Potocnik, European Commissioner for Environment, said “The recently published second edition of the SIN list, which also includes substances with endocrine disrupting properties, should indicate to you the substances the European Commission will take into consideration for placement on the candidate list.” Potocnik also referred to the European Commission’s goal that another 90 substances should be added to the Candidate List for Authorization by the end of next year: “Now that we are working at full speed getting 136 substances of very high concern on the REACh candidate list by 2012, and even more by 2020, the dream of green chemistry is becoming a reality.”

Companies manufacturing, importing, or using chemicals in the EU will undoubtedly take seriously Mr. Potocnik’s remarks.  Moreover, they are certain to continue monitoring the SIN List and consider its potential implications when making product and raw material selections.

Six SVHCs Selected for Burdensome Authorization Process under REACh

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REACh:

On February 11, 2011, the European Commission (EC or Commission) announced that six substances of very high concern (SVHC) have been moved from the so-called “Candidate List” to Annex XIV of the regulation known as “REACh.”  Annex XIV lists those substances subject to the “authorisation” procedures set out in Title VII of the regulation.  The six substances are the first to be selected for authorisation.  They are: 5-ter-butyl-2,4,6-trinito-m-xylene (musk xylene); 4,4′-diaminodiphenylmethane (MDA); hexabromocyclododecane (HBCDD); bis(2-ethylexyl) phthalate (DEHP); benzyl butyl phthalate (BBP); and dibutyl phthalate (DBP).  The substances were selected for authorisation because it was determined that they are carcinogenic, toxic for reproduction, or persist in the environment and accumulate in living organisms. 

Now that the substances are subject to authorisation, they will be banned from use or placement on the market within the next three to five years, unless an authorisation is granted to individual companies to continue their specific use(s).  Companies wanting to use these substances or place them on the market will need to demonstrate that the required safety measures have been taken to adequately control the risks, or that the benefits for the economy and society outweigh the risks.  Where feasible alternative substances or techniques exist, a timetable for substitution will also have to be submitted.

For each substance, a “sunset date” is provided, ranging from 2014 to 2015.  From this date, the substance may only be placed on the market or used if an authorisation has been granted or an application for authorisation has been made before the “latest application date” (i.e., the date by which anyone wishing to keep using a listed chemical after the sunset date must make an application).  Companies must submit their applications to the European Chemicals Agency (ECHA).  The Agency’s Risk Assessment Committee and Socio Economic Committee will then consider each application and submit their opinions to the Commission. The Commission will make the final decision concerning whether to grant authorisation.

Readers should recall that the authorisation requirements apply regardless of the tonnage at which the substance is placed on the market or used.  There are no lower limits for the authorisation requirement.  However, some uses of substances, such as intermediates, may be excluded. 

More information about this development is available here.  An overview of the authorisation process is available here and here.  Guidance on preparing an application for authorisation is available here.  And a current version of the SVHC Candidate List is available here.